EUCTR2010-020515-37-BE进行中（未招募）1 期
A single arm, open-label, multicenter study evaluating the long-term safety, tolerability and efficacy of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with multiple sclerosis.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Patients who have completed designated ongoing or planned trials with fingolimod, including phase II/III patients who have already completed CFTY720D2399, CFTY720D2309/E1 or one of the phase II/III core or extension studies.
- •3. Patients who participated in any designated global fingolimod MS trial other than phase II/III (e.g. CFTY720D2316, CFTY720D2320, etc.) and are less than 180 days beyond the time of local approval and general reimbursement.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •Patients fulfilling any of the following criteria are not eligible for
- •inclusion in this study:
- •1. Premature permanent discontinuation from any fingolimod study due
- •a. An adverse event or serious adverse event or laboratory abnormality.
- •b. Conditions leading to permanent study drug discontinuation.
- •Patients who temporarily or permanently discontinued from any
- •fingolimod study because of pregnancy can be re-enrolled.
- •2. Pregnant or nursing (lactating) women where pregnancy is defined as
- •the state of a female after conception and until the termination of
- •gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml).
- •3. Women of child-bearing potential, defined as all women
- •physiologically capable of becoming pregnant, UNLESS they are using
- •highly effective contraception during the study and for 2 months after
- •stopping treatment. 'Highly effective contraception'defined as
- •contraception which results in less that 1% unwanted pregnancies when
- •used properly according to the label.
- •Women are considered post-menopausal and not of child-bearing
- •potential if they have had 12 months of natural (spontaneous)
- •amenorrhea with an appropriate clinical profile (e.g. age appropriate,
- •history of vasomotor symptoms) or have had surgical bilateral
- •oophorectomy (with or without hysterectomy) or tubal ligation at least
- •six weeks prior to baseline. In the case of oophorectomy alone, only
- •when the reproductive status of the woman has been confirmed by
- •follow up hormone level assessment is she considered not of child
- •bearing potential.
- •4. Chronic disease of the immune system other than MS which may
- •require immunosuppressive treatment.
- •5. Severe active infection or active chronic infection.
- •6. Previous treatment with cladribine, cyclophosphamide or
- •mitoxantrone.
- •7. Treatment with monoclonal antibodies (including Natalizumab) in the
- •past 3 months.
- •8. Uncontrolled diabetes (HbA1c>9%).
- •9. Macular edema at Baseline.
- •10. Any medically unstable condition that may interfere with the
- •patient's ability to cooperate and comply with the study procedures, as
- •assessed by the treating physician.
- •11. Any of the following cardiovascular conditions:
- •a. myocardial infarction within the past 6 months prior to enrollment or
- •current unstable ischemic heart disease;
- •b. cardiac failure at time of Screening (Class III & IV, according to New
- •York Heart Association Classification) or any severe cardiac disease as
- •determined by the investigator;
- •c. patients receiving current treatment with Class Ia and III
- •antiarrhythmic drugs (e.g., quinidine, disopyramide, amiodarone,
- •bretylium, sotalol, ibulitide, azimilide, dofelitide, ajmaline,
- •procainamide);
- •d. second-degree AV block Type II or third-degree AV block or corrected
- •QTc inverval >500 msec;
- •e. sick sinus syndrome or sino-atrial heart block;
- 另有 11 项未显示
研究者
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